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When courts challenge the FDA’s authority, they put patients’ lives at risk

The entire biotechnology and pharmaceutical industry will be thrown into turmoil if judges can second-guess the scientific expertise of the US Food and Drug Administration.
  1. Rachel King

    1. Biotechnology Innovation Organization, Washington, DC, USA.

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In April 2023, US District Court Judge Matthew Kacsmaryk not only allowed a legal challenge to FDA's approval of mifepristone, but also indicated that it was likely to succeed. The ruling generated immense controversy because the drug can be used to terminate pregnancies. But the implications of the judge's order, which the US Supreme Court has temporarily blocked from taking effect, go far beyond the ongoing debate over reproductive rights.

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Nature Medicine 29, 1896 (2023)

doi: https://doi.org/10.1038/d41591-023-00051-5

Competing interests

R.K. is the chief executive officer of the Biotechnology Innovation Organization; is a co-founder, former chief executive officer and board member of GlycoMimetics; and serves on the board of Novavax.

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